Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy

Key facts

Study ID

NCT01068704

Run by

Bristol-Myers Squibb

People needed

4

Starts

2010-06-01

Expected to finish

2010-12-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Documented invasive breast cancer
• Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
• HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
• Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
• ECOG Performance status = 0 or 1

You may not qualify if…

• Prior hormonal therapy for metastatic disease
• Prior hormonal therapy with letrozole for adjuvant disease
• Symptomatic brain metastases
• Prior treatment with any tyrosine kinase inhibitor

Where it is running

• Texas Oncology-Abilene — Abilene, Texas, United States
• Texas Oncology-Beaumont — Beaumont, Texas, United States
• Us Oncology Central Pharmacy — Fort Worth, Texas, United States
• Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States
• Local Institution — La Rioja, La Rioja Province, Argentina
• Local Institution — Rosario, Santa Fe Province, Argentina
• Local Institution — Colima, Colima, Mexico
• Local Institution — Lima, Lima Province, Peru

Full record on ClinicalTrials.gov

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